VK2735 for Weight Management Phase 2 (Venture Oral Dosing)

Phase 2

Recruiting

• Conditions: Weight Loss
• Interventions: Drug: Placebo; Drug: VK2735

• Registration Number: NCT06828055
• Lead Sponsor: Viking Therapeutics, Inc.

Brief Summary

This is a phase 2, 13-week randomized, double-blind, placebo-controlled, parallel arm dose-finding study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 Oral Formulation in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition.

VK2735 or matched placebo will be administered once daily.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-18
• Status Verified: 2025-02
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-10
• Study First Posted: 2025-02-14
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-08
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

1. Age ≥18 years of age at the time of signing the informed consent.

2. Body mass index (BMI) ≥30 kg/m2 OR ≥27 kg/m2 with at least one weight-related co-morbid condition (treated or untreated), and BMI <50 kg/m2

   • Weight-related co-morbid conditions include hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease.
   • BMI calculated at the Screening visit will be used to determine eligibility.

Exclusion Criteria

1. History of or current clinically significant medical or psychiatric disorder that, in the opinion of the Investigator, does not support study participation
2. Self-reported body weight change of 5% or more within 3 months of screening
3. Current or past diagnosis of diabetes mellitus (including type 1, type 2, gestational)
4. Current or past diagnosis of chronic pancreatitis
5. Calcitonin ≥50 ng/L measured by central laboratory at screening (individuals with elevated calcitonin at initial screening may be re-screened)
6. Any GLP-1 receptor agonist or GLP-1/GIP dual agonist within 6 months of Screening
7. Any prescription or over-the-counter medications intended for weight loss within 6 months of screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Assignment	Placebo	VK2735 (Placebo) administered Daily
Active Assignment (Dose #1)	VK2735	VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
Active Assignment (Dose #2)	VK2735	VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
Active Assignment (Dose #4)	VK2735	VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
Active Assignment (Dose #6)	VK2735	VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
Active Assignment (Dose #3)	VK2735	VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily
Active Assignment (Dose #5)	VK2735	VK2735 is a peptide GLP-1 and GIP dual agonist administered Daily

Primary Outcome Measures

Name	Time	Method
Percent (relative) change from baseline in body weight after 13 weeks of treatment	13 Weeks	To measure the efficacy of oral VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects losing ≥5% and ≥10% of baseline weight at Week 13. Observed and change from baseline in body weight (kg) after 13 weeks of treatment	13 Weeks	To measure the efficacy of oral VK2735 for weight loss in adult Subjects who are obese, or overweight with at least one weight-related comorbid condition

Trial Locations

Locations (15)

Viking Clinical Site #111; 🇺🇸 Peoria, Arizona, United States

Viking Clinical Site #101; 🇺🇸 Clearwater, Florida, United States

Viking Clinical Site #100; 🇺🇸 Indianapolis, Indiana, United States

Viking Clinical Site #110; 🇺🇸 Louisville, Kentucky, United States

Viking Clinical Site #112; 🇺🇸 Kansas City, Missouri, United States

Viking Clinical Site #103; 🇺🇸 Knoxville, Tennessee, United States

Viking Clinical Site #104; 🇺🇸 Austin, Texas, United States

Viking Clinical Site #105; 🇺🇸 Lake Forest, California, United States

Viking Clinical Site #108; 🇺🇸 Largo, Florida, United States

Viking Clinical Site #106; 🇺🇸 San Antonio, Texas, United States

Viking Clinical Site #107; 🇺🇸 Ocoee, Florida, United States

Viking Clinical Site #102; 🇺🇸 Port Orange, Florida, United States

Viking Clinical Site #109; 🇺🇸 Saint Peters, Missouri, United States

Viking Clinical Site #114; 🇺🇸 Marrero, Louisiana, United States

Viking Clinical Site #113; 🇺🇸 Butte, Montana, United States